The system is intended to be used with leads and associated extensions that are compatible with the system. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Free from the hassles of recharging. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Household appliances. Neuromodulation. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. away from the generator and avoid placing any smart device in a pocket near the generator. Component manipulation by patient. This includes oxygen-enriched environments such as hyperbaric chambers. IPGs contain batteries as well as other potentially hazardous materials. Damage to the system may not be immediately detectable. Do not crush, puncture, or burn these devices because explosion or fire may result. Security, antitheft, and radiofrequency identification (RFID) devices. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Neurosurgery Pain Management Orthopaedic Surgery New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Activities requiring coordination. Abandoned leads and replacement leads. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Equipment is not serviceable by the customer. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Pediatric use. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. The system is intended to be used with leads and associated extensions that are compatible with the system. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Case damage. If multiple leads are implanted, leads and extensions should be routed in close proximity. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Component manipulation by patients. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. All components listed must be implanted unless noted as "optional." *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Stimulation Modes. Programmer and controller devices are not waterproof. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. Patient's visual ability to read the patient controller screen. See Full System Components below if the patient has an IPG and extensions implanted. Securing the IPG. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Physicians should also discuss any risks of MRI with patients. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. MR safety: spinal cord stimulators - Questions and Answers in MRI If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. The Eterna SCS System is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Sheath insertion precaution. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. This equipment is not serviceable by the customer. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Risk of depression, suicidal ideations, and suicide. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. IMAGINE A FUTURE - cloud.neuroemail.abbott.com For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This may occur once the lead is in place and is connected to the neurostimulator and activated. Low frequencies. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Do not suture directly onto the lead to avoid damaging the lead. Implantation of multiple leads. Follow proper infection control procedures. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Up to two leads, lead protection boots, and burr hole covers may be implanted. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Consumer goods and electronic devices. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. MRI Support | Abbott Neuromodulation A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Store components and their packaging where they will not come in contact with liquids of any kind. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Component handling. Expiration date. Using surgical instruments. Multiple leads. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. This damage could result in loss of therapy, requiring additional surgery for system replacement. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Preventing infection. To prevent injury or damage to the system, do not modify the equipment. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Electrical medical treatment. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Case damage. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. communication equipment (such as microwave transmitters and high-power amateur transmitters). Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Return them to Abbott Medical for proper disposal. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Patients should cautiously approach such devices and should request help to bypass them. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. If lithotripsy must be used, do not focus the energy near the IPG. FDA's expanded . Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom Patient activities and environmental precautions. Lead movement. Use extreme care when handling system components prior to implantation. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Stimulation effectiveness. Set the electrosurgery device to the lowest possible energy setting. Getting an MRI | Medtronic Postural changes. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Spinal Cord Stimulator Systems - Boston Scientific Bathing. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Failure to provide strain relief may result in lead migration requiring a revision procedure. If needed, return the equipment to Abbott Medical for service. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Advance the needle and guidewire slowly. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. The implanted components of this neurostimulation system are intended for a single use only. Wireless use restrictions. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. (2) The method of its application or use. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. For more information, see the clinician programmer manual. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Application modification. FDA Approves Abbott's Spinal Cord Stimulation for People Living with Use extreme care when handling system components. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Damage to the system may not be immediately detectable. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Diathermy is further prohibited because it may also damage the neurostimulation system components. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Mobile phones. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Device components. Physicians should also discuss any risks of MRI with patients. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. THE List - MRI Safety Lead movement. Number of leads implanted. ** Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. The effect of mobile phones on deep brain stimulation is unknown. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Stylet handling. Surgeon training. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. However, some patients may experience a decrease or increase in the perceived level of stimulation. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Patients should cautiously approach such devices and should request help to bypass them. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Set the electrosurgery device to the lowest possible energy setting. Providing strain relief. Infection. Device modification. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. six to eight weeks after implantation of a neurostimulation system. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. For this reason, programming at frequencies less than 30 Hz is not recommended. If interference occurs, try holding the phone to the other ear or turning off the phone. Radiofrequency or microwave ablation. Securing the lead with the lead stabilizer will mitigate this risk. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Diathermy is further prohibited because it may also damage the neurostimulation system components. External defibrillators. Diathermy is further prohibited because it may also damage the neurostimulation system components. Operating the device near gas fumes or vapors could cause them to catch fire. Follow proper infection control procedures. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. If the stylet is removed from the lead, it may be difficult to reinsert it. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Return any suspect components to Abbott Medical for evaluation. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Return all explanted components to Abbott Medical for safe disposal. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.